FDA recall Z-0289-2021

Product

Merge LIS

Reason for recall

A defect in the software resulted in medications that are not associated with the patient (i.e., medications that the patient is not currently taking) appearing on their report.

Distribution

Domestic Distribution Only: Alabama, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kentucky, Louisiana, Maryland, Michigan, Mississippi, Oklahoma, Tennessee, Texas.

Key facts

Status

Terminated

Initiation date

2017-01-23

Report date

2020-11-04

Termination date

2021-05-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hartland, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0289-2021